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Gadavist Side Effects

Generic Name: gadobutrol

Note: This document contains side effect information about gadobutrol. Some of the dosage forms listed on this page may not apply to the brand name Gadavist.

For the Consumer

Applies to gadobutrol: intravenous solution

Along with its needed effects, gadobutrol (the active ingredient contained in Gadavist) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking gadobutrol:

Rare
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • confusion
  • convulsions
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • general feeling of discomfort or illness
  • hives or welts, itching, or skin rash
  • loss of consciousness
  • paleness of the skin
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • sweating
  • tightness in the chest
  • unusual tiredness or weakness
Incidence not known
  • Bluish color of the fingernails, lips, skin, palms, or nail beds
  • burning sensation
  • burning, dry, or itching eyes
  • chest pain
  • cough
  • deep bone pain
  • difficulty with swallowing
  • discharge or excessive tearing
  • hoarseness
  • increased sweating
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle stiffness or weakness
  • no blood pressure or pulse
  • no breathing
  • noisy breathing
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • skin rash, swelling, hardness, tightness, burning, itching, or red or dark patches
  • slow or irregular breathing
  • sneezing
  • stiff joints or trouble moving
  • stopping of the heart
  • swelling of the mouth or throat
  • unconsciousness

Some side effects of gadobutrol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Headache
  • nausea
Rare
  • Change in sense of smell
  • change in taste
  • dizziness
  • dry mouth
  • feeling hot or cold
  • loss of taste
  • unusually warm skin
  • vomiting

For Healthcare Professionals

Applies to gadobutrol: intravenous solution

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity/anaphylactoid reaction[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness, paresthesia, dysgeusia
Rare (less than 0.1%): Loss of consciousness, convulsion, parosmia[Ref]

Gastrointestinal

Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Vomiting
Rare (less than 0.1%): Dry mouth[Ref]

Dermatologic

Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Vomiting
Rare (less than 0.1%): Dry mouth[Ref]

Cardiovascular

Rare (less than 0.1%): Tachycardia, palpitation, pallor
Postmarketing reports: Cardiac arrest[Ref]

Respiratory

Respiratory side effects have included dyspnea.[Ref]

Local

Uncommon (0.1% to 1%): Injection site reactions[Ref]

Ocular

Very rare (less than 0.01%): Eyelid edema[Ref]

Other

Uncommon (0.1% to 1%): Feeling hot
Rare (less than 0.1%): Malaise, feeling cold[Ref]

General

The most common adverse reactions were headache, nausea, and dizziness.[Ref]

References

1. "Product Information. Gadavist (gadobutrol)." Bayer Pharmaceutical Inc, West Haven, CT.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Some side effects of Gadavist may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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